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AzTrials

Breast CancerPhase 2EFESENCT02866955

Evaluation of the Efficacy of Estramustine in Patient With Breast Cancer Progression After Treatment With Aromatase Inhibitor.

A Phase 2 study testing Estramustine and Tamoxifen in people with Breast Cancer, run by Institut de Cancérologie de Lorraine at 21 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Despite advances in early detection and treatment strategy, about 25 to 40% of patients treated for breast cancer develop metastasis. Some patients are in a therapeutic impasse situation. It is therefore necessary to consider all possible options. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Estramustine and Tamoxifen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
21 sitesFrance
Study dates
15 Jun 2011to 28 Aug 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Post-menopausal women or women receiving Luteinizing hormone-releasing hormone (LHRH) analogs
  • Histologically confirmed metastatic breast cancer RH+
  • Measurable metastatic breast cancer (modified RECIST criteria) or not measurable but evaluable
  • Recurrence:
  • being treated with aromatase inhibitors (AIs)
  • after adjuvant treatment by AIs
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  • after progression of the metastatic cancer in patients receiving AIs following positive response during at least 6 months
  • Performance status ≤ 2
  • Haematological test: polynuclear neutrophiles ≥ 1.5 × 109 /L, haemoglobin ≥ 9 g/dL, blood platelet ≥ 100 × 109 /L
  • Hepatic function: albumin ≥ 2.5 g/dL, serum bilirubin ≤ 1.5 × N (except if Gilbert's Syndrome) , aminotransferases ≤ 3 × N (≤ 5 × N if hepatic metastases)
  • Renal function: serum creatinine ≤ 1.5 mg/dL or clearance of creatinine ≥ 40 ml/min
  • Women without endometrial pathology
  • Ability to provide written informed consent before the start of any study specific procedures

Who cannot join

  • Age < 18 years old
  • Pre-menopausal, pregnant or pregnant or breast feeding females
  • Patient who should exclusively be treated by chemotherapy
  • Women previously treated with chemotherapy but not by AIs
  • Women previously treated by tamoxifen for their metastatic breast cancer
  • HER2+
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  • Concurrent anti-cancer treatment (chemotherapy, surgery, immunotherapy, biological therapy and tumour embolism)
  • Concurrent treatment with protocol-defined prohibited medications
  • Malabsorption syndrome , significant digestive dysfunction, gastrectomy, jejunectomy, hemorrhagic recto colon
  • Concurrent disease or condition that may interfere with study participation, or any serious medical disorder that would interfere with the subject's safety (for example, active or uncontrolled infection or any psychiatric condition prohibiting understanding or rendering of informed consent)
  • Any pathology, including severe psychiatric or psychologic disease that may harm patient's safety or participation in the study
  • Serious or not cured or unstable toxicity due to the administration of another drug being involved in clinical trials
  • Uncontrolled cardiovascular pathologies
  • Previous history of thromboembolic event like deep vein thrombosis or pulmonary embolism recorded within one year before the inclusion date
  • Active uncontrolled infection
  • Existence of an increased risk of thromboembolic event, apart from the metastatic cancer condition, such as:
  • known presence of antiphospholipid antibody
  • family history of thrombophilia
  • existence of any clinical, genetic, or biological abnormality which can increase the risk of thromboembolic event according to the
  • Participation to a clinical trial at least 4 weeks prior the start of the study

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

France21 sites

  • Institut Sainte Catherine

    Avignon, 84082

  • CHU Besançon-Jean Minjoz

    Besançon, 25030

  • Polyclinique de Blois

    Blois, 41260

  • CHU Avicenne

    Bobigny, 93009

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33077

  • CHRU Brest

    Brest, 29200

  • Centre O. Lambret

    Lille, 59020

  • CLCC Léon Bérard

    Lyon, 69373

  • Hôpital Privé Clairval

    Marseille, 13009

  • CHBM Site du Mittan

    Montbéliard, 25200

  • CLCC Val d'Aurel

    Montpellier, 34298

  • Centre Catherine de Sienne

    Nantes, 44202

  • Centre Antoine Lacassagne

    Nice, 06189

  • CHU Tenon

    Paris, 75020

  • Hôpital Européen Georges Pompidou

    Paris, 75908

  • Institut Jean Godinot

    Reims, 51056

  • Polyclinique Courlancy Reims

    Reims, 51100

  • Clinique armoricaine

    Saint-Brieuc, 22015

  • Centre Paul Strauss

    Strasbourg, 67000

  • Clinique Sainte Anne

    Strasbourg, 67085

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54519

Other trials in France

About this study

Despite advances in early detection and treatment strategy, about 25 to 40% of patients treated for breast cancer develop metastasis.

Some patients are in a therapeutic impasse situation. It is therefore necessary to consider all possible options. The Estramustine showed encouraging results in the treatment of metastatic breast cancer.

Given the clinical data, the answer rate of Estramustine and its impact on progression free survival deserve to be studied in earlier clinical situation.

This Phase II study evaluated the efficacy of Estramustine in women with breast cancer and metastates, already treated with aromatase inhibitors and for whom this treatment has failed.

Conditions
Breast Cancer
Being tested
Estramustine, Tamoxifen
Keywords
aromatase inhibitors, Metastases
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EstramustineDrug

    Also called estramustine phosphate

    140mg/4 caps/day

  • TamoxifenDrug

    20mg/day

Study groups in NCT02866955
Study groupRoleWhat they receive
GROUP E (Estramustine)OtherPatients with HER2-/RH+ breast cancer progressing after having already undergone a first line adjuvant treatment by estramustine
Receives: Drug: Estramustine
GROUP T (Tamoxifen)OtherPatients with HER2-/RH+ breast cancer progressing after having already undergone a first line adjuvant treatment by tamoxifen
Receives: Drug: Tamoxifen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival after a 6- month monotherapy with Estramustine in patients with HER2-/RH+ breast cancer progressing

    proportion of patients in progression-free survival (PFS) after a 6-month treatment is defined as the duration of objective response or stabilisation of the disease according to the Recist criteria.

    The following events shall be considered as progressive :

    • Relapse
    • Treatment intolerance leading to stop the treatment
    • Death

    Measured: up to 6 months

Secondary outcomes (6)

  1. Risks of thrombosis

    risks of thrombosis assessed by the analysis of biomarkers (D-Dimer, prothrombin fragment 1+2, von Willebrand factor, fibrinogen, Chain Reaction Protein)

    Measured: up to 6 months

  2. Clinical benefit of estramustine

    clinical benefit of estramustine assessed by RECIST criteria

    Measured: 1 year

  3. Correlation between the answer rate and biomarkers

    answer rate (RECIST criteria) and level of biomarkers (Lactate déshydrogénase, Antigène carcino-embryonnaire and Cancer antigène 15-3)

    Measured: 1 year

  4. Tolerance of estramustine treatment

    Toxicity (Common Terminology Criteria for Adverse Events)

    Measured: 1 year

  5. Tolerance of tamoxifen treatments

    Toxicity (Common Terminology Criteria for Adverse Events)

    Measured: 1 year

  6. Proportion of patients developing thromboembolic events

    proportion of patients developing thromboembolic events assessed in the 2 groups every month during the one-year patient follow-up

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2016 (estimated)
  2. Study start15 Jun 2011
  3. Primary completion8 Aug 2014
  4. Study completion28 Aug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02866955
Sponsor's protocol ID
2009-017788-40
Other IDs
2009
Acronym
EFESE
Status last verified
Mar 2020
First submitted
8 Aug 2016
Last updated
9 Mar 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Estramustine and Tamoxifen in people with Breast Cancer, run by Institut de Cancérologie de Lorraine at 21 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival after a 6- month monotherapy with Estramustine in patients with HER2-/RH+ breast cancer progressing (time frame: up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02866955.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2020.

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